Senior Scientist, Research & Development

About This Role

This senior scientist role involves managing and coordinating all scientific activities within the Research & Development department, focusing on applied research, new product/service development, clinical trials, and data analysis. The position also includes managing the Applied Regenerative Medicine Laboratory and requires a commitment to BioBridge Global's core values.

Responsibilities

• Manage and coordinate all scientific activities for BBG-R&D
• Conduct, supervise assigned regenerative medicine-related research and development, including analytical assays
• Train and supervise junior staff and implement all relevant facility policies and procedures
• Manage and coordinate all research, early new product and/or service development, and specialty projects, including any clinical-trial support and Investigational New Drug (IND) studies
• Assist in managing the BBG-R&D lab
• Perform literature searches and hands-on laboratory investigation in support of product and/or service development
• Spearhead new product development of tissue engineered products and solutions
• Work with internal and external clients to set Target Product Profile (TPP) and Critical Quality Attributes (CQA) for new products and services
• Apply Quality by Design (QbD) methodology and Design of Experiments (DoE) approach in development to maximize capacity and reduce cost of goods
• Coordinate and maintain alignment of investigative activities with other subsidiaries
• Lead and/or assist in technology transfer, GAP analysis, and industrialization of process
• Responsible for troubleshooting, deviation investigation, and product impact assessment for projects
• Organize and prioritize work to meet timelines and ability to execute on multiple projects
• Apply for appropriate grants and studies relevant to regenerative medicine
• Design and develop cGLP documentation for generation and maintenance of a stable human-derived stem cell line
• Expand and differentiate xeno-free human-derived stem cells
• Develop and conduct lineage-specific functional assays for stem cells and extracellular vesicles
• Expand, differentiate and cryopreserve stem cells
• Isolate, process and characterize extracellular vesicles and cryopreservation
• Perform analytical method development and testing
• Responsible for publication of abstracts and papers for BBG-R&D
• Evaluate and/or develop new product and service offerings and make recommendations for improvement to existing BBG-R&D offerings
• Responsible to assure that all BBG-R&D equipment are performing within specifications
• Collaborate and work effectively with other industry leaders, internal and external BBG-R&D clients, staff, suppliers, and regulatory agencies
• Participate in regional, national, and international scientific forums on behalf of BBG-R&D
• Provide guidance to team-oriented work projects for the development and implementation of strategic initiatives - validations, process improvements, and Standard Operating Procedures (SOPs)
• Participate in executive team strategic planning and business plan execution
• Participate in internal and external audits/inspections
• Utilize performance excellence principles by using data and facts to plan and make decisions
• Ensure that organizational goals/strategic objectives are converted to appropriate actions to align work
• Measure and monitor progress toward achieving the goals/strategic objectives
• Display positive leadership skills and champion strategic and management directives with department staff by committing to and embracing the mission, vision, and core values of BBG-R&D
• Be dedicated to the highest standards of quality and adhere to all safety, regulatory, and quality requirements
• Foster an atmosphere of open, honest communication and knowledge sharing among workers in business units throughout the organization
• Demonstrate respect for co-workers and management
• Consistently improve performance outcomes in customer satisfaction, worker engagement (motivation and satisfaction), operational excellence, innovation, and financial performance
• Maintain a positive work attitude and participate in self-improvement as an effective leader
• Always maintain a professional demeanor while representing BBG-R&D
• Perform duties of the management under your supervision during their absences
• Provide world-class customer service by capturing and being responsive to the voice of the customer through multiple feedback channels
• Resolve issues and drive satisfaction in accordance with BBG customer engagement, feedback, and complaint processes

Requirements

• Doctoral Degree (e.g., Ph.D., M.D., O.D., or equivalent) from an accredited college or university
• Five or more years of relevant life science experience
• Ability to correctly interpret process outcomes
• Working knowledge of laboratory and research systems
• Knowledge of on-line research tools and databanks
• Knowledge of and perform according to Standard Operating Procedures (SOPs) and policies
• Familiarity with regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.
• Working knowledge of laboratory sciences and techniques
• Ability to recognize and facilitate resolution of unusual results or difficulties encountered in all phases of laboratory work
• Excellent hands-on laboratory skills
• Strong computer skills
• Ability to solve technical and/or clinical problems with biotechnology-based solutions
• Capable of evaluating, interpreting, and reporting accurate/valid test results by current testing methodologies
• Excellent interpersonal and public speaking skills
• Ability to keep information confidential
• Neat in appearance and well groomed
• Ability to work with interruptions, meet deadlines, and perform accurate laboratory testing
• Energetic, enthusiastic and have a team-oriented leadership style
• Professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently
• Perform well in repetitive work situations
• Ability to conduct experiments and correctly interpret test results
• Ability to work independently as well as in a team environment

Nice to have:

• Three or more years of management/leadership experience
• Regenerative medicine applied research and product development experience
• Regenerative medicine-related assay development experience
• Hands-on experience with flow, PCR, mass spectroscopy and cell-based potency assays
• In vivo model product performance testing experience

Important Details

• Occupational Exposure Assignment: Category I

About the Company

BioBridge Global is committed to its Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE).